The Effect of a Low-fat Vegan Dietary Intervention on Intracellular Lipid, Insulin Sensitivity, and Glycemic Control in Type 2 Diabetes

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2, Diabetes Mellitus Type 2 in Obese

In brief

The goal of this 16-week clinical trial is to assess the health benefits of a low-fat vegan diet on insulin sensitivity and glycemic control in type 2 diabetes. Participants will receive at no cost, study-related weekly nutrition education classes and one-on-one consultation with a registered dietitian.

Key facts

Study ID

NCT06106035

Run by

Physicians Committee for Responsible Medicine

People needed

26

Starts

2024-02-13

Expected to finish

2025-11-28

Last updated by the study team

2026-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women with type 2 diabetes treated by diet and/or oral hypoglycemic agents other than sulfonylureas
• Age ≥18 years
• Body mass index 26-40 kg/m2
• Medications (antidiabetic, antihypertensive, and lipid-lowering) have been stable for the past 3 months
• HbA1c between 6.0-10.5% (42-91 mmol/mol)

You may not qualify if…

• Diabetes mellitus, type 1 and/or treatment with insulin or sulfonylureas
• Metal implants, such as a cardiac pacemaker or an aneurysm clip
• History of any endocrine condition that would affect body weight, such as thyroid disease, pituitary abnormality, or Cushing's syndrome
• Smoking during the past six months
• Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
• Use of recreational drugs in the past 6 months
• Use within the preceding six months of medications that affect appetite or body weight, such as estrogens or other hormones, thyroid medications, systemic steroids, antidepressants (tricyclics, monoamine oxidase inhibitors, selective serotonin reuptake inhibitors), antipsychotics, lithium, anticonvulsants, appetite suppressants or other weight-loss drugs, herbs for weight loss or mood, St. John's wort, ephedra, beta-blockers
• Pregnancy or intention to become pregnant during the study period
• Unstable medical or psychiatric illness
• Evidence of an eating disorder
• Likely to be disruptive in group sessions
• Already following a low-fat, vegan diet
• Lack of English fluency
• Inability to maintain current medication regimen
• Inability or unwillingness to participate in all components of the study
• Intention to follow another weight-loss method during the trial

Where it is running

• Physicians Committee for Responsible Medicine — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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